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NCT Number: NCT05692674

A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction

The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1: Patients with pathologically confirmed breast cancer

2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction

3: No distant metastasis

4: Had no chest and breast radiotherapy history

5: Between the ages of 18 and 80

6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy

7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women

8: The patient must sign the informed consent form for receiving radiotherapy.

Exclusion criteria

  • 1: No pathological confirmation；

2: Distant metastasis；

3: Had chest and breast radiotherapy history

4: Organs at risk could not achieve safe dose

5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women

6: Poor general health status, i.e. KPS<70, or ECOG>2

7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；

8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.

Treatment and study plan

adjuvant hypofractionated intensity-modulated proton radiotherapy

Radiation

CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

Primary outcomes

  1. the failure rate of breast reconstruction after hypofractionated proton radiotherapy

    Time frame: within 2 years after hypofractionated proton radiotherapy

    Reoperation

Secondary outcomes

  1. Acute and late toxicities

    Time frame: within 5 years after radiotherapy

    Treatment related toxicity assessed by CTCAE v4.03

  2. Tumor local control rate, overall survival rate and progression free survival rate

    Time frame: within 5 years after radiotherapy

    The Ipsilateral breast and regional lymph nodes recurrence, death and progression

Sponsors and collaborators

Lead sponsor

Shanghai Proton and Heavy Ion Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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